This study will compare the benefit for patients switching from Kaletra® to Invirase® tablets over remaining on Kaletra® (based on randomization), to elicit the lipid benefits inferred in previous studies

A 24-week, Randomized, Open-label, 2-arm Study to Compare the Safety, Efficacy and Tolerability of Invirase® Tablets With Ritonavir Versus Kaletra® Tablets in HIV 1 Infected Adults on a Kaletra® Based Regimen With 2 Nucleosides/Nucleotides

This is a prospective, phase IV, multicentre, randomised, open-label, 2-arm, 24-week study. Approximately 130 HIV-1 infected patients on a stable antiretroviral regimen containing Kaletra® with 2 nucleoside/nucleotide analogues will be randomized to 1 of 2 treatment arms: saquinavir with ritonavir 1000/100 mg BID (using Invirase® tablets) or lopinavir/ritonavir 400/100 mg BID (using Kaletra® tablets).Eligibility for enrollment will be determined at a screening visit that will occur within 30 days of the baseline visit. Protocol-defined study assessments will take place at clinic visits at the end of Weeks 4, 12, and 24.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male or non-pregnant, non-nursing females >18 years of age

Seropositive for HIV-1

On an antiretroviral combination of Kaletra® with 2 nucleoside/nucleotide analogues for at least 6 months

Ability and willingness to provide written informed consent and adhere to the study regimen

Females of childbearing potential must have a documented negative serum or urine pregnancy test at screening/baseline and ensure that 2 reliable forms of contraception are being used, including a barrier method, for the duration of the study and for 90 days after the last dose of study medication

Any current known clinical or laboratory parameter of ACTG Grade 4 (see Appendix 4). However, asymptomatic Grade 4 abnormalities will be permitted at the discretion of the investigator if deemed clinically appropriate. Abnormalities deemed insignificant by the investigator must be discussed with the sponsor prior to enrollment.

Evidence of active, untreated opportunistic infection, intercurrent illness, drug toxicity or any other condition such that in the judgment of the investigator the patient would not be able to take or continue a prescribed antiretroviral regimen

Malignancy requiring chemotherapy or radiotherapy

Known hypersensitivity to any of the prescribed antiretroviral drugs or formulation components

Evidence of alcohol and/or drug or substance abuse that in the judgment of the investigator would likely result in the patient being unreliable in fulfilling the conditions of the protocol

History of psychological illness or conditions that in the judgment of the investigator might interfere with the patient's ability to understand the requirements of the study

History of drug non-adherence that in the judgment of the investigator would result in the patient being unreliable in fulfilling the conditions of this protocol

Patients who had received an investigational new drug within the last 4 weeks

Currently taking, or anticipate taking during the course of the study, any drug contraindicated with the antiretroviral drugs they have been randomized to receive

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438152